Zerion Alpha, Zerion Beta

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name: Zerion Alpha, Zerion Beta FDA UDI
Generic Name: Dental bridge, ceramic FDA UDI
Device Name: zerion HSC zirconium oxide ceramic 15 units bridge framework FDA UDI
Model / Reference: Bridges (tooth borne) FDA UDI
Description: zerion HSC zirconium oxide ceramic 15 units bridge framework FDA UDI

Identifiers

Catalog Number: 010.0015 FDA UDI
Primary DI / UDI-DI: 07630031701435 FDA UDI
FDA Product Code: EIH FDA UDI
GMDN Term: Dental bridge, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Dental bridge, ceramic

Zerion Alpha, Zerion Beta by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Institut Straumann SA

Sources (1)

FDA UDI 15c3d588-e00c-40e1-b3e2-5136a1b75e28 35 fields · synced Jun 6, 2026